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Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma

NCT06302400 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-09-19

No results posted yet for this study

Summary

The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:

* What is the safety and toxicity profile of the 166-Holmium microspheres?
* Is the device effective in treating HCC?

Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:

* A Computed Tomography (CT) scan
* A Magnetic Resonance Imaging (MRI) scan
* Blood tests
* Quality of life questionnaires

Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DEVICE

166Holmium microspheres (QuiremSpheres®)

QuiremSpheres® are a biocompatible microsphere that contain the radionuclide holmium-166 (166Ho), which emits gamma-radiation (81 keV) and high-energy (1.81 MeV) beta-particles.

Sponsors & Collaborators

  • Terumo Europe N.V.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Rohini Sharma, Professor · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2025-03-04
Completion
2025-03-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302400 on ClinicalTrials.gov